MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number NM-401L-0623

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

As reported, in the beginning of the procedure, after the injector force max needle was primed with the solution, the solution would not flow through the needle tip after it was extended passed the sheath.There was no patient injury or harm reported due to the event.No user injury reported.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation and inspection found and noted the following below: the lot no.Was 12v24.The user¿s complaint was replicated.Visual inspection on the received condition and noted white foreign residue lodged inside the insertion portion tube.The white residue inside of the tube is in various sections throughout.The handle section appears normal, and the needle was fully retracted upon being received.Functional testing was performed and was able to fully extend and retract the needle out of the sheath without using excessive force.Further, the injection inspection was tested by filling a syringe with water and attaching it to the injection port.The water was unable to be injected, and the movement from the syringe was restricted.Attempted to apply more force to the syringe and the white foreign residue did not expel out the distal end.Attempted to extend the needle from the distal end side of the insertion portion and test the injection of fluid in both pushed and pulled directions.The syringe was again attached to the complaint device and fluid from the syringe did not pass through when in a pulled position.The pushed position still did not allow the fluid to pass through.Review of the device history record for the lot indicated no abnormalities with the event-related items.Process inspection sheet.Quality inspection sheet.Nonconforming product report.The ifu (instruction for use) contains the following descriptions, and it warns against this event.Straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.Operate the slider slowly, otherwise the tube could buckle.When inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.Insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.Stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.From evaluation results and a similar complaint in the past, it was likely that the phenomenon occurred due to the compressive bucking on the needle tube.It is unlikely a unit with defective needle is shipped as nm-401l series undergo 100% inspection for appearance, needle operation and injection.Therefore the compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.It was likely that the friction between the outer tube and the needle increased by the following factors.The needle extended/retracted while the tube was coiled in inspection of operation.The slider was abruptly pushed.The kink of the tube.Angle of the distal end of the endoscope olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report is being submitted to correct the aware date (g3) from the initial mdr from november 19, 2021 to november 5, 2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13003779
• MDR Text Key: 283275995
• Report Number: 8010047-2021-16105
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422669
• UDI-Public: 04953170422669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0623
• Device Lot Number: 12V 24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1